Biktarvy bictegravir 50 mg emtricitabine 200 mg tenofovir alafenamide 25 mg
1 INDICATIONS AND USAGE BIKTARVY is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in: adults and pediatric patients weighing at least 14 kg: who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known or suspected substitutions associated with resistance to bictegravir or tenofovir [see Dosage and Administration (2.4) , and Use in Specific Populations (8.1) ]. BIKTARVY is a three-drug combination of bictegravir (BIC), a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI), and emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV-1 nucleoside analog reverse transcriptase inhibitors (NRTIs), and is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 14 kg: who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known or suspected substitutions associated with resistance to bictegravir or tenofovir. ( 1 )
gilead sciences, inc.
OVAL BROWN GSI 9883
GSI 9883 OVAL BROWN
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16 HOW SUPPLIED/STORAGE AND HANDLING BIKTARVY tablets are available in bottles and blister packs: Bottle 50 mg/200 mg/25 mg tablets each contain 50 mg of bictegravir (BIC), 200 mg of emtricitabine (FTC), and 25 mg of tenofovir alafenamide (TAF). These tablets are purplish brown, capsule-shaped, and film-coated with "GSI" debossed on one side and "9883" on the other side (NDC 61958-2501-1). 30 mg/120 mg/15 mg tablets each contain 30 mg of BIC,120 mg of FTC, and 15 mg of TAF. These tablets are pink, capsule-shaped, and film-coated with "GSI" debossed on one side and "B" on the other side (NDC 61958-2505-1). 30 mg/120 mg/15 mg tablets each contain 30 mg of BIC,120 mg of FTC, and 15 mg of TAF. These tablets are pink, capsule-shaped, and film-coated with a non-functional bisecting score line on one side and "BVY" on the other side (NDC 61958-2506-1). Each bottle contains 30 tablets, a silica gel desiccant, polyester coil, and is closed with a child-resistant closure. Do not remove the desiccant packet. Store bottle below 30 °C (86 °F). Keep bottle tightly closed. Blister Pack 50 mg/200 mg/25 mg tablets each contain 50 mg of BIC, 200 mg of FTC, and 25 mg of TAF. These tablets are purplish brown, capsule-shaped, and film-coated with "GSI" debossed on one side and "9883" on the other side (NDC 61958-2501-3). Each blister pack contains 30 tablets (4 strips each containing 7 tablets and 1 strip containing 2 tablets). Blister packs are sealed with a child-resistant laminated foil lidding material (peel-push), and each blister cavity contains a die-cut desiccant film which is heat staked to the foil lidding material. Store blister pack at 25 °C (77 °F), excursions permitted to 15–30 °C (59–86 °F) (see USP Controlled Room Temperature). Dispense only in original containers.
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